20 July 2022 | Wednesday | News
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The partnership will accelerate stockpiling, channel distribution and hospital access for the amubarvimab/romlusevimab combination in China
The amubarvimab/romlusevimab combination is the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, evaluated through a randomized, double-blind, placebo-controlled trial
The amubarvimab/romlusevimab combination was commercially launched in China on July 7, 2022
Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced that TSB Therapeutics (Beijing) Co., Ltd. ("TSB Therapeutics"), a joint venture majority-owned by the Company, is partnering with China Resources Pharmaceutical Commercial Group Co., Ltd. ("CR Pharma Comm") to advance stockpiling, channel distribution and hospital access for the Company's long-acting neutralizing monoclonal antibody (mAb) therapy, the amubarvimab/romlusevimab combination. The two parties are working together to ensure timely drug supply that supports the COVID-19 pandemic prevention and control efforts in China. The collaboration will also explore other novel partnership opportunities to enable expanded access of the combination therapy in China.
On December 8, 2021, the National Medical Products Administration (NMPA) of China approved the amubarvimab/romlusevimab combination for the treatment of adults and pediatric patients (age 12-17 weighing at least 40 kg) with mild and normal type of COVID-19 at high risk for progression to severe disease, including hospitalization or death. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval. On March 15, 2022, the National Health Commission of China added the amubarvimab/romlusevimab combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) for the treatment of COVID-19. On July 7, 2022, the amubarvimab/romlusevimab combination was made commercially available in China.
"As the COVID-19 pandemic continues to impact the health of communities worldwide, we are proud to bring the amubarvimab/romlusevimab combination to patients in urgent need in China, and pleased with the 27-month timeline on which we were able to expedite this important work," said Rogers Luo, President and General Manager, Greater China of Brii Bio, and Chief Executive Officer of TSB Therapeutics. "In 2019, Brii Bio started a strategic partnership with China Resources Group to jointly build an integrated industrial chain of life sciences. CR Pharma Comm is a large-scale pharmaceutical distribution enterprise owned by China Resources Pharmaceutical Group, which has an extensive drug marketing and channel distribution network. This strong and strategic partnership and unique operating model enables Brii Bio to rapidly expand access to our amubarvimab/romlusevimab combination to help more COVID-19 patients in China, and we look forward to exploring in-depth collaborative efforts with China Resources Pharmaceutical Group down the line for the long-term benefit of patients and the healthcare community."
"We are thrilled that this important combination therapy is now commercially available as part of China's COVID-19 pandemic prevention and control strategy, enabling the treatment to quickly reach a much greater number of patients and provide meaningful clinical benefit to those in need. Brii Bio's success developing this combination therapy highlights the scientific innovation and infectious disease expertise coming out of the China biotechnology space," said Hong Mu, Chairman of CR Pharma Comm. "China Resources Group is a state-owned enterprise with an 83-year history of confronting profound healthcare risks and challenges, including those seen with the COVID-19 pandemic. CR Pharma Comm will work together with our subsidiaries across the country to fight on the front line, actively respond to the national strategy, strongly assist the government in stockpiling for emergency use, provide sufficient pharmaceuticals and medical equipment to medical institutions for pandemic prevention and control, ensure peoples' safety with timely medications, and practice the mission and undertaking of CR Pharma Comm."
On July 9, 2022, through the joint efforts of Brii Bio and CR Pharma Comm, the first batch of the combination therapy was successfully delivered to the Third People's Hospital of Shenzhen, and the first patient was dosed. From May to December 2021, Brii Bio donated nearly 3,000 doses of the amubarvimab/romlusevimab combination for emergency use in 22 hospitals in 21 cities as part of its commitment to ensure humanitarian access and to help curb the outbreaks of the pandemic. Nearly 1,000 patients received the treatment of the combination therapy. These real-world data provide important clinical application and safety data in China. The subsidiaries of CR Pharma Comm made a great contribution in delivering the drugs to the hospitals for clinical treatment of patients.
With the commercialization of the amubarvimab/romlusevimab combination, the Company will actively cooperate with its business partners, make every effort to improve accessibility, and advance drug stockpiling at all levels, to quickly respond to the sudden outbreak of COVID-19 and protect peoples' lives.